BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2232063 · Received September 1, 2011

    Report

    Report Number
    2050012-2011-04769
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 5, 2011
    Report Date
    August 5, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER FIELD SERVICE ENGINEER (FSE), THE INSTRUMENT WAS ON STANDBY ON HIS ARRIVAL. FSE CHECKED WASH CONCENTRATE VALVES AND CANISTER AND FOUND NO SIGN OR INDICATION OF DAMAGE. FSE REMOVED AND EMPTIED THE SOLUTION. FSE PUT BACK THE CANISTER AND PRIMED AND THE CANISTER FILLED WITH NO ISSUES. THE ISSUE WAS RESOLVED AND THE CUSTOMER DID NOT CALL BACK TO REPORT ANY ISSUE RELATING TO THIS PROBLEM. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) STATING THAT THEY GOT A MESSAGE ON THE UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM THAT THE WASH CONCENTRATE RESERVOIR WAS NOT FILLING. WHEN THEY CHECKED THE BOTTLE THEY FOUND THAT WASH CONCENTRATE WAS BUBBLING OUT OF THE RESERVOIR. THE CUSTOMER WAS WEARING GLOVES AND A LAB COAT. NO INJURY OR EXPOSURE WAS REPORTED AND NO ERRONEOUS RESULTS WERE GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 800 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1